510(k) · Cleared
ClearedBptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood Pressure and Temperature Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vsm Medtech, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 21, 2003 as substantially equivalent to K994423 (Vsm Medtech, Ltd., 2000) and 3 other predicates after a 186-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 21, 2003
- Review
- 186 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K951193 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK951193 Clinical Vital Signs Monitor, Model #52STP-E1Tycos Instruments, Inc. · 1996
- This deviceK023078 Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated…Vsm Medtech, Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951193 | Clinical Vital Signs Monitor, Model #52STP-E1 | Tycos Instruments, Inc. | 1996 | — |
| 0 (this device) | K023078 | Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated… | Vsm Medtech, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994423 | Automated Non-Invasive Blood Pressure Monitor, Model BPM-100Summary page 1…Number (Owner/Operator): 9034609 Predicate Device Information: VSM Technology BpTRU Automated Non-Invasive Blood Pressure Monitor (Model BPM- 100) as cleared by K994423, KO02046 and KO 12636 Tycos Instruments Clinical Vital Signs Monitor, Model #52STP-E as cleared by K951193. Rev 1… | 2000 |
| * | K002046 | Modification to Automated Non-Invasive Blood Pressure Monitor, Model BPM-100 | 2000 |
| * | K012636 | Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100 | 2001 |
| * | K951193 | Clinical Vital Signs Monitor, Model #52STP-E1Summary page 1…Blood Pressure Monitor (Model BPM- 100) as cleared by K994423, KO02046 and KO 12636 Tycos Instruments Clinical Vital Signs Monitor, Model #52STP-E as cleared by K951193. Rev 1 Page 15 September 13,2002 VSM MedTech Ltd.… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K994423.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The BpTRU Vital Signs Monitor:
Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older.
Measures temperatures in subjects 3 years of age or older.
Is intended for use in physicians’ offices, nursing units, and patient care areas of hospitals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023078: Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood Pressure and Temperature Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023078
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026